Recall Z-1171-2016 ยท LDP Colorimetry, Acetaminophen
Sekisui Diagnostics P.E.I. Inc.
Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.
| Date | Jan 22, 2016 |
| Status | Terminated |
| Reason | Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover |
| Root cause | Device Design |
| Action | Sekisui sent an Important Field Correction - Customer Notification letter dated January 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Discard all reagent in house with a current expiration date of 2016-09. 2. Update the expiration on all remaining kits on hand with the new expiration dates provided 3. When adding additional reagent to the analyzer, a new reagent wedge should be used. 4. If crystals are observed within reagent stored on-board, reagent should be discarded and replaced with fresh reagent. |
| Quantity | 14,407 kits. |
| Distribution | Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, IA, ID, IL, MA, , MN, MT and ND., and to the countries of Canada, France and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081938 | ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 Genzyme Diagnostics P.E.I., Inc., May 1, 2009 |